FDA-filed SPL labeling · retrieved through openFDA

Lemborexant

Lemborexant is a prescription sleep aid used to treat insomnia — difficulty falling asleep and/or staying asleep — in adults.

Brand name Dayvigo
Drug class ⓘ Orexin Receptor Antagonist
Rx Schedule CIV Form 1 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveFeb 24, 2025
AvailabilityRx
Earliest approval/marketing year ⓘ2020
FDA-listed product records ⓘ9
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 24, 2026
⭐ Lemborexant at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Dayvigo (lemborexant) is a once-nightly prescription tablet that treats insomnia in adults by blocking the brain's wake-promoting signals. It works well for sleep but carries real risks — especially next-day drowsiness, complex sleep behaviors, and interactions with alcohol and many common medications. Take it only as directed, leave yourself a full 7 hours to sleep, and never combine it with alcohol.

📖 Lemborexant: Patient Information Guide

A plain-language walkthrough of Lemborexant — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Lemborexant (brand name: Dayvigo) is approved for one indication in adults:

  • Dayvigo tablets are used to treat insomnia — specifically, trouble falling asleep, trouble staying asleep, or both.
  • It is approved for use in adults only; safety and effectiveness have not been established in children.
⚙️How it works▾

Your brain produces chemicals called orexins (also called hypocretins) that actively promote wakefulness. Lemborexant is an orexin receptor antagonist — it blocks the two receptors (OX1R and OX2R) that orexins attach to. By blocking these receptors, it prevents orexins from sending their wake-up signals to the brain. With that signal quieted, your brain can more easily transition into sleep.

A key breakdown product of lemborexant in the body, called M10, also blocks these same receptors with similar strength — meaning the sleep-promoting effect continues as the drug is processed.

💊How it's taken▾

Dayvigo tablets are taken by mouth once per night, right before getting into bed, with at least 7 hours of sleep time remaining. Your prescriber may start you at a lower dose and adjust based on how well it works and how you tolerate it — the maximum is one tablet per night. Taking Dayvigo with or shortly after a meal, especially a high-fat one, can delay how quickly it kicks in by about 2 hours, so it is best taken on an empty stomach or before eating.

  • Take only once per night — never take a second dose the same night.
  • If you have moderate liver impairment, your maximum dose is lower; Dayvigo is not recommended at all for severe liver impairment.
  • If you are on certain other medications (CYP3A inhibitors or inducers), your dose may need to be adjusted — ask your pharmacist or prescriber.
🤒Side effects — in detail▾

The most common side effect of Dayvigo is drowsiness — this can carry over into the next day. Other reported side effects include:

  • Somnolence (sleepiness), fatigue, sluggishness, or lethargy
  • Headache
  • Nightmares or unusual dreams
  • Next-morning grogginess or impaired alertness and coordination

More serious reactions — including complex sleep behaviors (doing things while asleep with no memory of it), sleep paralysis, vivid hallucinations near sleep, cataplexy-like leg weakness, worsening depression, or thoughts of self-harm — require immediate medical attention. Stop Dayvigo and call your doctor right away if any of these occur.

⚠️Warnings & precautions▾
  • Next-day impairment and driving: Dayvigo can affect your alertness, balance, and driving ability the morning after taking it. This risk is higher at the higher dose, if you get less than 7 hours of sleep, or if you combine it with alcohol or other sedating drugs. Older adults face a higher risk of falls.
  • Complex sleep behaviors: Some people have walked, driven, eaten, made phone calls, or had sex while asleep — with no memory afterward. This can happen even on the first dose. Stop Dayvigo immediately and call your doctor if this happens.
  • Depression and suicidal thoughts: A slightly higher rate of suicidal thoughts was seen in Dayvigo users compared to placebo. People with depression need extra monitoring. Report any new or worsening mood changes right away.
  • Sleep paralysis and hallucinations: Brief inability to move while waking up, or vivid dream-like experiences between sleep and waking, can occur. These are real effects — tell your doctor if they happen.
  • Breathing problems: Use with caution if you have sleep apnea, COPD, or other respiratory conditions — the effect on breathing should be considered by your prescriber.
  • Persistent insomnia: If sleep does not improve after 7–10 days of treatment, contact your doctor — another underlying condition may need to be evaluated.
🔀What it interacts with▾

Lemborexant interacts with several medications and substances. Here are the most important ones to know:

  • Alcohol: Combining Dayvigo with alcohol makes balance and memory problems significantly worse — avoid alcohol entirely while taking it.
  • Strong or moderate CYP3A inhibitors (e.g., itraconazole, clarithromycin, fluconazole, verapamil): These raise lemborexant levels in the blood and increase the risk of side effects — avoid combining with Dayvigo.
  • Strong or moderate CYP3A inducers (e.g., rifampin, carbamazepine, St. John's wort, modafinil, efavirenz): These lower lemborexant levels and may make it less effective — avoid combining.
  • Weak CYP3A inhibitors (e.g., ranitidine, chlorzoxazone): These modestly raise Dayvigo levels — a lower maximum dose of Dayvigo applies when used together.
  • Other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants): Add to drowsiness and impairment — use only under close prescriber supervision, with possible dose adjustments.
  • Bupropion or methadone (CYP2B6 substrates): Dayvigo may reduce the effectiveness of these drugs — your prescriber should monitor your response and adjust doses if needed.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Narcolepsy: Dayvigo is contraindicated (must not be used) in people with narcolepsy.
  • Liver disease: People with moderate liver impairment need a lower maximum dose. Dayvigo is not recommended for severe liver impairment.
  • Depression or suicidal thoughts: Extra caution and monitoring are needed. Only the smallest feasible supply should be dispensed at a time.
  • Breathing problems (sleep apnea, COPD): Discuss with your prescriber before starting — effects on respiration should be considered.
  • Older adults: Higher risk of falls due to drowsiness and impaired coordination. Use with extra caution.
  • Children: Safety and effectiveness have not been established — not approved for pediatric use.
  • Pregnancy: No human data on safety during pregnancy. A voluntary pregnancy registry is available (call 1-866-961-2388). Discuss risks with your doctor.
  • Breastfeeding: Small amounts of lemborexant pass into breast milk. Watch breastfed infants for excessive sedation. Discuss the benefit-risk balance with your doctor.
🚑If you take too much▾

Taking too much Dayvigo is likely to cause significant drowsiness. There is no specific antidote for a lemborexant overdose. If you suspect an overdose, get medical help immediately or call Poison Control at 1-800-222-1222. Because lemborexant binds strongly to proteins in the blood, dialysis is not expected to help remove it from the body.

📡Pharmacodynamics — effects in the body▾

Lemborexant attaches to and blocks orexin receptors (OX1R and OX2R) in the brain, which suppresses the wake-promoting signals those receptors normally carry. Studies show it does not meaningfully affect heart rhythm (QTc interval) even at doses far above the recommended amount. However, when combined with alcohol, lemborexant significantly worsens balance and memory compared to alcohol alone — an effect measurable around 2 hours after taking a dose.

🔬Pharmacokinetics — how your body processes it▾

After taking Dayvigo by mouth, peak blood levels are reached in about 1 to 3 hours. Eating a large, high-fat meal before taking it delays that peak by roughly 2 hours. Lemborexant is broken down mainly by liver enzymes (CYP3A4/3A5), and most of the drug leaves the body through the feces and urine. It binds heavily to proteins in the blood (about 88–94%), which is why dialysis cannot effectively remove it in an overdose. With regular use, some accumulation in the body occurs over time.

📦How to store it▾

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) .

📄 Written from Lemborexant’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

195

Supplements & herbs that interact with Lemborexant

195 supplements and herbal products have documented interactions with Lemborexant in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 9
  • Moderate · 147
  • Minor · 39
Every supplement checked against Lemborexant — ranked by severity The full interaction hub: 9 major · 147 moderate · 39 minor · every one linked to its full report. Check Lemborexant against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Lemborexant — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly does Dayvigo do — how does it help me sleep? ▾
Your brain has a built-in wake system driven by chemicals called orexins. When those orexins are active, they keep you alert. Dayvigo blocks the receptors those chemicals attach to, so it essentially turns down your brain's 'stay awake' signal. That makes it easier for your brain to shift into sleep mode. It's a different approach than older sleep aids like benzodiazepines, which work more broadly on the nervous system.
When should I take it, and does it matter if I eat first? ▾
Take Dayvigo right before you get into bed — only when you have at least 7 full hours before you need to wake up. It's best to take it away from a big meal. If you eat a heavy, high-fat meal right before taking it, it can delay how quickly the medication kicks in by about 2 hours. That doesn't mean it won't work; it just means it may take longer to feel the effect.
Will I feel groggy the next morning? ▾
Possibly, especially when you first start or if you're on the higher dose. Dayvigo can affect your alertness, balance, and driving ability the morning after — not just at bedtime. Until you know how it affects you, be cautious about driving or doing anything that needs your full concentration. And never combine it with alcohol, which makes that grogginess significantly worse.
I heard people can do things in their sleep on sleep medications — is that true with this one? ▾
Yes, it can happen. Complex sleep behaviors — like sleepwalking, sleep-driving, eating, making phone calls, or even having sex while asleep — have been reported with Dayvigo. The tricky part is that people usually have no memory of these events afterward. It can happen on the very first dose. If you or someone around you notices this, stop taking Dayvigo and call your doctor right away. This is one of the most serious risks to be aware of.
Are there medications or things I should avoid while taking Dayvigo? ▾
Yes — a few important ones. Avoid alcohol completely while taking Dayvigo; the combination hits balance and memory much harder than either alone. Also avoid St. John's wort, rifampin, or carbamazepine, which can make Dayvigo less effective. Antifungals like itraconazole or fluconazole, and some antibiotics like clarithromycin, can push Dayvigo levels too high. Always tell your pharmacist or doctor everything else you're taking, including supplements, so they can check for interactions.
Is it safe to take if I'm pregnant or breastfeeding? ▾
There's no solid human data yet on how Dayvigo affects a pregnancy. If you're pregnant or trying to get pregnant, talk to your doctor to weigh the risks and benefits — there is a voluntary pregnancy registry you can join (call 1-866-961-2388). If you're breastfeeding, small amounts of lemborexant do pass into breast milk, so watch your baby for any unusual sleepiness. Discuss the best option for your situation with your doctor.
Is Lemborexant available over the counter? ▾
Lemborexant is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
Is Lemborexant a controlled substance? ▾
Yes — Lemborexant is a federally controlled substance (Schedule IV) in the United States, so how it is prescribed, refilled and dispensed is regulated by the DEA.
When was Lemborexant first available? ▾
Lemborexant has been available in the United States since at least 2020, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Lemborexant? ▾
Lemborexant is supplied by 2 manufacturers listed in the FDA NDC Directory, including Eisai Inc., Eisai Manufacturing Ltd.

💬 Answers drafted from Lemborexant’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Lemborexant comes

Lemborexant is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
Brands Dayvigo
How this form is used
What it may be used for
  • Dayvigo tablets are indicated to treat insomnia in adults who have difficulty falling asleep, staying asleep, or both.
Important instructions
  • Dayvigo tablets are taken by mouth once per night, immediately before going to bed.
  • Dayvigo should only be taken when at least 7 hours of sleep time remain before you need to wake up.
  • Taking Dayvigo with or right after a meal — especially a high-fat, high-calorie meal — can delay the time it takes to work; best taken away from food.
  • Do not take more than one Dayvigo tablet per night; follow your prescriber's dosing instructions exactly.
Available strengths 2 strengths
9 FDA-listed product records ⓘ

📊 Lemborexant across the U.S. market

How Lemborexant appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms ⓘ
2
Manufacturers
1
Brand names
9
FDA-listed product records ⓘ
2020
First marketed ⓘ
Eisai Inc.78%
Eisai Manufacturing Ltd22%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Lemborexant is used

A general measure of how commonly Lemborexant is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Lemborexant is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

16,038
Medicaid prescriptions filled (Q1–Q4 2025)
$5.3M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Lemborexant prescribed? Of the 1,597 medications we measure, Lemborexant ranks #842 by Medicaid prescriptions — more than 47% of them.

Where Lemborexant ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Lemborexant product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 10 mg oral tablet is the most-dispensed Lemborexant product — about 70% of these Medicaid prescriptions.

lemborexant 10 MG Oral Tablet Most dispensed

11,233 Medicaid prescriptions (Q1–Q4 2025) 70% of Lemborexant prescriptions shown $3.7M gross reimbursement (before rebates) ≈ $331 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2288425

lemborexant 5 MG Oral Tablet

4,805 Medicaid prescriptions (Q1–Q4 2025) 30% of Lemborexant prescriptions shown $1.6M gross reimbursement (before rebates) ≈ $335 per prescription (gross)

Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2272408

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Lemborexant, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 8 listed Lemborexant NDCs with Medicaid activity.

🔍 Compare Lemborexant products

A representative set of FDA-listed product records for Lemborexant — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Tablet
5 mg Oral Eisai Inc. × 4 listings NDA View NDC →
10 mg Oral Eisai Inc. × 3 listings NDA View NDC →
5 mg — Eisai Manufacturing Ltd DRUG FOR FURTHER PROCESSING View NDC →
10 mg — Eisai Manufacturing Ltd DRUG FOR FURTHER PROCESSING View NDC →

Showing 9 of 9 products — FDA National Drug Code Directory. See every product, package size and price: browse all 9 Lemborexant NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Lemborexant RxCUI 2272403 1 dose form · 2 strengths
  1. Dose form (SCDF) Oral Tablet RxCUI 2272407 In current FDA listings
    Clinical drug / strength (SCD) 5 MG RxCUI 2272408 10 MG RxCUI 2288425

Look up RxCUI 2272403 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Dayvigo

🏭 Manufacturers & labelers

Eisai Inc. 7 Eisai Manufacturing Ltd 2

RxNorm drug class

Lemborexant belongs to the Orexin Receptor Antagonist class.

Pharmacologic class Orexin Receptor Antagonist
Drug family (ATC) Orexin receptor antagonists
How it works Cytochrome P450 2B6 Inducers, Orexin Receptor Antagonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Feb 24, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Lemborexant.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Lemborexant after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
NDC products indexed
9
Distinct labelers/manufacturers represented
2
Linked representative label ⓘ
Eisai Inc.
Linked label effective
Feb 24, 2025
Composite sections available
25
Linked SPL Set ID
7074cb65-77b3-45d2-8e8d-da8dc0f70bfd
Linked SPL Document ID
c82838dc-6934-4541-8a02-bd44ee5bb82a
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Eisai Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.